FDA.reportPublic FDA data

SurgiCase Planner

Primary DI
E314SURGICASEKNEEPLAN0
Brand
SurgiCase Planner
Company
Materialise NV
Model
SurgiCase Knee Planner
Catalog number
SurgiCase Knee Planner
Device description
SurgiCase Knee Planner
Published
2018-10-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
OOGKnee Arthroplasty Implantation System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/PolymerOrthopedic2
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerOrthopedic2
OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + AdditiveOrthopedic2
OOGKnee Arthroplasty Implantation SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150928000
K162273000
K172650000
K173445000
K173970000
K202207000
K251554000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150928000Materialise TKA Guide System, Materialise TKA Planner, Materialise TKA GuidesMaterialise NV2015-08-10JWH
K162273000Materialise TKA Guide SystemMaterialise NV2016-11-07JWH
K172650000Materialise PKA Guide SystemMaterialise NV2017-11-20HSX
K173445000Materialise TKA Guide SystemMaterialise NV2018-02-02JWH
K173970000Materialise PKA Guide SystemMaterialise NV2018-07-06HSX
K202207000Materialise PKA Guide SystemMaterialise NV2020-10-02HSX
K251554000Materialise TKA Guide SystemMaterialise NV2025-07-14JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E314SURGICASEKNEEPLAN0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
CAD/CAM softwareA software program intended to provide computer-aided design (CAD) or computer-aided manufacturing (CAM) functionality for the production of patient-specific custom-made devices (e.g., orthopaedic implants, dental devices, anatomical models), treatment planning, simulation, and/or robotic capabilities for device production (e.g., 3-D printing). It may include functionality to upload patient-specific images and to facilitate communication between healthcare professionals.

Regulatory Flags#

DUNS number
373139427
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05420060351228TruMatch CMF Titanium 3D Printed SplintsSD980.030SD980.0302026-10-20
E314SHCLM010101Lima PSISHC-LM01-01-01SHC-LM01-01-012016-12-01
E314SHCLM020101Lima PSISHC-LM02-01-01SHC-LM02-01-012016-12-01
E31480403057Match Point System804-03-057804-03-0572016-09-24
E31480425148Match Point System804-25-148804-25-1482016-09-24
E314SHCLM010001Lima PSISHC-LM01-00-01SHC-LM01-00-012016-12-01
E314SHCLM010201Lima PSISHC-LM01-02-01SHC-LM01-02-012016-12-01
E314SHCLM020001Lima PSISHC-LM02-00-01SHC-LM02-00-012016-12-01
E314SHCLM020201Lima PSISHC-LM02-02-01SHC-LM02-02-012016-12-01
E31442100200Signature42-10020042-1002002026-09-24
E31442100300Signature42-10030042-1003002026-09-24
E31442411410Signature42-41141042-4114102026-09-24
E31442422415Signature42-42241542-4224152026-09-24
E31442422450Signature42-42245042-4224502026-09-24
E31442422451Signature42-42245142-4224512026-09-24
E31442422452Signature42-42245242-4224522026-09-24
E31442422453Signature42-42245342-4224532026-09-24
E31442422455Signature42-42245542-4224552026-09-24
E31442422456Signature42-42245642-4224562026-09-24
E31442422457Signature42-42245742-4224572026-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
TKRL0001F1540PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0001F1540PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL0001F1540PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001F1B80PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001F1B80PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL0001F1B80PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0001F34K0PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001F34K0PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL0001F34K0PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0001F6000PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001F6000PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0001F6000PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL0001F7300PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001F7300PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL0001F7300PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0001F7940PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL0001F7940PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0001F7940PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001F7F80PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0001F7F80PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001F7F80PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL0001F9F00PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0001F9F00PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001F9F00PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL0001FF640PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001FF640PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL0001FF640PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0001FLI00PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0001FLI00PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL0001FLI00PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20